Quality objectives and documentation
GALVANTA COMPANY LIMITED has adopted quality objectives for pharmaceutical manufacturing.
These objectives describe the company’s intended manufacturing framework. They are not evidence of completed implementation, an inspection outcome or certification.
Adopted objectives
- Maintain a documented quality system governing all manufacturing activities.
- Ensure all personnel complete required training on operational procedures and applicable Cambodian requirements.
- Implement documented procedures for the qualification and maintenance of manufacturing equipment.
- Conduct regular internal audits to verify adherence to established operational procedures.
- Control and document the procurement and receipt of all manufacturing materials.
Documents and implementation
A policy objective must be distinguished from the records demonstrating its implementation.
Questions about a quality system should identify the relevant activity and the document required. Completion of a particular procedure, training record, audit, supplier assessment or equipment qualification requires evidence of implementation separate from a general objective.
The website does not publish a certificate or claim a validated operational system.
Manufacturing records and changes
For a proposed activity, documentation needs to identify responsibilities, instructions, relevant changes and the records required to demonstrate the work performed.
The existence and scope of particular records must be established through documentary evidence. A completed batch, investigation or release decision requires its own records.
Laboratory and stability enquiries
Laboratory testing and stability studies are separate technical subjects. An operating laboratory, accredited method, qualified storage chamber or study result requires evidence separate from inclusion in the Services directory.
Relevant enquiry pages are Analytical and microbiology and Stability studies.
Quality documents
Email [email protected], identifying the document, subject and reason for the request. A request does not establish that a document exists or can be disclosed.
See Regulatory information for the distinction between corporate records and pharmaceutical permissions.
Product concerns
Use Product-quality concerns and recall correspondence to report a suspected defect or send a recall-related message.
For an unwanted medical occurrence, follow Adverse-event reporting. Do not wait for a company reply when urgent medical assistance is needed.
Prerequisites
The company holds no pharmaceutical manufacturing licence or GMP certificate. Any proposed work requires evidenced capability, applicable authorisations and a separate agreement.